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EMA ŰƮ١ɵ𺸿 RWE 
2019-06-22 06:20:27
EMA ŰƮ١ɵ𺸿 RWE 
2019-06-22 06:20:27

򰡿 '̿ ӻٰ Ȱ ' ߰

ָ䡤ƾ 10 Ұ

ű 㰡 Ȯ  Ȱ
ֱ 迡 ָ ޴ 'ӻٰ(RWE)' ؿܿ  Ȱǰ .

̱ FDA EMA RWE Ȱ ʰ '̿Ǿǰ RWDRWE Ȱ ' ֱ ߰ƴ.

ǰǾǰ򰡿 ߰ 10 ʸ Ұϰ ִ.

ָ ٺÿ ߸ý ŰƮ ɵ TNF ƾ ۶ Ǽ ȯ ̿Ǿǰ ġ ̴.

 6 ʰ RWE Ȱߴ. ű 㰡 ʸ 3, ϳ ġ ȯ Ȯ 㰡濡 Ȱ ʿ. ޿ డ ʴ .

߽ (ŰƮ) = EMA 2018 ŰƮ RWE Ȱߴ. ŰƮٰ 㰡 ȹ 2015 7 3 ̾.

üδ Ǻ ̻ 󵵿 ŰƮ , ġ ˾ƺ ӻ2 迡 ߴ ȯڸ ȣƮ .

ش ȯڱ 3 , ׷쿡 Ǻ ۿ ȯڿ ׷ ȯڰ ˷ ŷ, , , ġ̷ ̾.

, Ǻ ۿ ȯ Ⱓ Ÿ. ġ޴ ߿ Ŀ Ǻ ۿ Ȯ پٴ ؼ̴.

EMA  . EMA 'ŰƮ 뿡 پ ġ ۿ ʰ ߻ , ġ ߴ Ŀ Ÿ Ƿ ߰ ͸ ʿϴ' ǰߴ.

߽ (ɵ) = ٸ 鿪׾ ɵ Ǿǰ MHPR RWE Ȱ Ȯεȴ.

ɵ𺸴 ̽ ź ִٴ Ǵ ̾.

̿ MHPR 2016 11 ʸ ϰ, ɵ𺸿 ŰƮٷ ġ ̽ ź Ȯε ȯ 9 Ȯߴ.

, ɵ ̽ ź ߻Ѵٴ Ȯεƴ. ᱹ MHPR 'ɵ 鿪 ϰ ̽ ź ִ' ߴ.

߽ű 㰡() = ׷ϸ ű 㰡 RWE Ȱ ʵ ִ. ʰ ǥ̴.

㰡 ޼(ALL) ȯ 189 ӻ2 2014 9 10, ̱ FDA EMA ߴ.

ű 㰡 㰡û ๰ϱ ߴ. ̱ 2010~2014 ϵ ALL ȯ 189 ӻ2 2014 9 FDA, 2014 10 EMA ߴ.

⿡ ߰ ߴ. 'Study 2012031'̶ ̸ (historical comparator) . RWD Ȱ ٸ ȯܿ ְ ּȭϰ ߴ.

, ALL ȯڰ , ߱ ð , ̽ġḦ Ȯεƴ. , ġ ȭп ġ ġᱺ üⰣ 2 Ÿ.


ᱹ, м ӻ ȿ Ȯεƴ. ̿ ̱ FDA 2014 12 ӻ3 ϴ ǸŸ 㰡ߴ. EMA 2015 11 Ǻ ǸŸ ߴ.

Ȯ(ָ) = 幰 Ȯ뿡 RWE Ȱ ʵ ִ. ͳġȯ ߰(PNH) ġ ָ.

ָ 2007 6 εƴ. ÿ ӻ ٰŷ ̷ ִ ȯڿԸ ֵ ε ๰̾.

׷ RWDκ ̷° ϰ PNH ȭǴ ӻ 뼺 Ȯεƴ.

PNH ȯ 1547 , ̷ ȯ ָ ׷ ׷쿡 Ÿ SDH ġ ƴٴ ̴.

̸ ٰŷ EMA 2015 2 ̷° PNH ȯڿ ָ ֵ Ȯߴ.
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ֽż ݴ
ٺ Ϲݾ ǸŰ (2024 04)
౹ 31
ǰ ְ
ѽŻ÷(10) 3,500 2,500 1,000 3,009
޾(100) 24,000 23,000 1,000 23,200
Ʒγΰ(100) 30,000 28,000 2,000 28,500
īɾ(10g) 7,000 6,000 1,000 6,559
Ľõ򿬰(5g) 5,000 4,500 500 5,138
Ź(4) 5,000 4,000 1,000 4,438
ڶ(20) 6,000 6,000 0 6,000
(10) 6,000 4,500 1,500 5,071
Ժ(10) 4,000 3,500 500 3,712
ڱ׸(20) 5,000 4,500 500 4,717
ť(10) 3,000 2,500 500 2,990
Ȱť(1) 1,200 900 300 1,182
Ǯɾ(3.3ml) 26,000 23,000 3,000 24,250
޵𿬰(10g) 7,000 5,900 1,100 6,289
öŸ(34) 13,000 11,000 2,000 11,866
뽺ī(20g) 22,000 18,000 4,000 20,184
ġ(1) 1,000 1,000 0 1,000
ӽ÷(21) 10,000 8,500 1,500 9,205
ͺ(10) 3,500 3,000 500 3,196
ݿ(1ڽ) 3,000 3,000 0 3,000
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,524
߽Ÿ(120) 70,000 50,000 20,000 60,385
Źĸ(10ĸ) 3,000 2,000 1,000 2,989
Ÿ̾(120) 60,000 50,000 10,000 51,538
տ(60ĸ) 29,000 25,000 4,000 27,600
Ÿ̷ER(6) 3,000 2,500 500 2,750
ٿ(30g) 12,000 9,000 3,000 11,444
(120) 25,000 22,000 3,000 24,991
Ʒ(6) 4,000 3,000 1,000 3,262
ǽõĸ(270ĸ) 110,000 110,000 0 110,000
B(120) 70,000 70,000 0 70,000
׳(10) 3,000 2,500 500 2,778
6̺(10) 3,000 3,000 0 3,000
(60) 230,000 220,000 10,000 223,333
Ⱦ 12,000 10,000 2,000 10,143
̰źĸ(60ĸ) 35,000 30,000 5,000 33,231
Ųť(20) 5,500 4,500 1,000 4,903
λ絹÷(100) 35,000 32,000 3,000 33,297
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